510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K844694Substantially Equivalent

Titmus Vision Tester II

Titmus Optical, Inc., Petersburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844694 is the FDA 510(k) clearance record for TITMUS VISION TESTER II, a class I device, cleared for Titmus Optical, Inc. on under FDA product code HIT (Tester, Color Vision). FDA records list 3 510(k) clearances for Titmus Optical, Inc., from to . As of , FDA records show no recalls naming K844694.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HIT Tester, Color Vision
Regulation
21 CFR 886.1170
Device class
Class I
Review panel
Ophthalmic
Applicant
Titmus Optical, Inc.
Third party review
No

Clearances, product code HIT

Trailing 12 months

FDA records hold no clearances under product code HIT in the trailing twelve months.

FDA records show no clearances under product code HIT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260